Carbofix Pedicle Screw System: Evaluation of the Clinical and Radiographic Outcomes of the Use of a Carbon Fiber Device Compared to Titanium Devices in Patients Undergoing Spinal Arthrodesis for Degenerative Spinal Diseases

Not Applicable

Recruiting

• Conditions: Degenerative Disc Disease
• Interventions: Procedure: Carbofix; Procedure: Titanium

• Registration Number: NCT06209684
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

Previous clinical study carried out on cancer patients at IOR Spine Surgery (approved in October 2014). The carbon device is indicated in patients suffering from vertebral tumors who need stabilization and will then carry out radiotherapy, because carbon has a practically zero level of interference with ionizing radiation. Carbon also allows for better visualization of the implants on MRI/CT and X-ray. There are no studies in the literature analyzing the use of carbon fiber devices in lumbar degenerative pathologies.

118 patients suffering from degenerative spinal pathology requiring 1 or 2 levels of lumbar or lumbosacral fusion will be valutated.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-29
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17
• Primary Completion: 2026-04-29
• Study Completion: 2027-04-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 118

Inclusion Criteria

• Patients suffering from degenerative spinal pathology or spondylolisthesis who require instrumented stabilization on 1-2 levels;
• Age greater than or equal to 18 years;
• Ability to understand and sign the informed consent to the study and to follow the required follow-ups.

Exclusion Criteria

• Metabolic bone disease.
• History of Paget's disease or other osteodystrophies, whether acquired or congenital, including renal osteodystrophy, hyperthyroidism, hypothyroidism, Ehlers-Danlos syndrome, osteogenesis imperfecta, achondroplasia.
• Neoplastic disease.
• History of mental disorder or current psychiatric treatment.
• Pregnancy.
• Immunodeficiency diseases.
• Infectious bone disease (discitis, osteomyelitis)
• Treatment with drugs that can interfere with bone metabolism
• Inability to understand and sign the informed consent to the study and to follow the required follow-up visits.
• Alcohol and/or drug abuse
• Obesity
• Metal allergy
• Participation in other studies on drugs or devices (within 30 days)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Carbofix	CarboFix implant for spinal surgery
Traditional	Titanium	Titanium implant for spinal surgery

Primary Outcome Measures

Name	Time	Method
Fusion rate	through study completion, an average of 1 year	Fusion rate after 12 months as demonstrated by computed tomography scan (CT scan).; The CT scan will be evaluated by Brantigan scale.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	after 6 months	A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
EuroQoL-5D	after 6 months	EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition
Short Form-12	after 6 months	The SF-12 is composed of 12 items (derived from the 36 of the original SF-36 questionnaire) which produce two measures relating to two different aspects of health: physical health and mental health.; The SF-12 is made up of 4 scales (physical functioning, role and physical health, role and emotional state, mental health) measured by 2 items each and 4 scales each measured by one item (physical pain, vitality, social activities and general health).
Classification system of surgical complications specific for spine	up to 12 months	rate of post-operative complications evaluated by SAVES classification system specific for spine
Oswestry Disability Index	after 6 months	The Oswestry Disability Index (ODI) is a self-administered and validated questionnaire in Italian which aims to evaluate disabilities in subjects suffering from low back pain in both the acute and chronic phases.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy